FDA 510(k)

OVENT

K-Number: K160234 · 2016-03-17

ApplicantOventus Manufacturing Pty, Ltd.

Decision Date2016-03-17

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OVENT is the device name listed in this FDA 510(k) record. The listed applicant is Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K160234. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVENT?

OVENT is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Oventus Manufacturing Pty, Ltd.. The 510(k) number is K160234.

When did OVENT receive FDA 510(k) clearance?

OVENT received FDA 510(k) clearance on 2016-03-17, under 510(k) number K160234.

Who is the listed applicant for OVENT?

The FDA 510(k) record lists Oventus Manufacturing Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OVENT?

The FDA product code for OVENT is LRK.

Other records listing Oventus Manufacturing Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190236O2Vent Optima K171316O2Vent W K161832O2VENT T

Related Devices (Code: LRK)

K261912SnØreNegatØrDnB Innovations, LLC K261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.